Amiodarone Usage After Ischemic Ventricular Tachycardia Ablation

• Conditions: ICD Shock; Ventricular Tachycardia; Ischemic Cardiomyopathy
• Interventions: Procedure: Ventricular tachycardia ablation

• Registration Number: NCT03244748
• Lead Sponsor: Yuksek Ihtisas Hospital

Brief Summary

Ventricular Tachycardia ablation in ischemic cardiomyopathy patients is required procedure in cases when anti-arrhythmic drugs failed. The concern is if adjunctive continuation amiodarone after ablation is needed.

Detailed Description

Ischemic cardiomyopathy patients have implantable cardioverter defibrillators (ICD) to prevent arrhythmic deaths. Ventricular tachycardia (VT) events with frequent ICD interventions in ischemic cardiomyopathy patients is encountered frequently. Frequents ICD interventions is associated with worse outcomes. Anti-arrhythmic drugs ,mostly amiodarone, are given prevent ventricular arrhythmias and ICD interventions that may not be curative. Ablation of ventricular tachycardia is the suggested treatment when anti-drugs are without effect. After ablation of ventricular arrhythmia the continuation of amiodarone is not well elucidated.

In this study we aimed to enroll ischemic cardiomyopathy patients having frequent ICD interventions despite medical treatment. VT ablation is performed and patients divided into two groups; group one continues having amiodarone after ablation, group two does not have amiodarone after ablation. Both groups will be compared in terms of recurrence and death.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2017-08
• Study First Submitted: 2017-08-05
• Study First Submitted QC: 2017-08-05
• Last Update Submitted: 2017-08-05
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09
• Primary Completion: 2018-01-01
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Ischemic cardiomyopathy patients applied with frequent ICD interventionor electrical storms and having ejection fraction below 50%. Frequent ICD defined as more than 1 ICD intervention within month. Electrical storm defined as more than 2 ICD intervention within one day.

Exclusion Criteria

Patients with cardiomyopathies other than ischemic etiology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Ventricular tachycardia ablation	Patients underwent ablation and continued having amiodarone after the procedure
Group 2	Ventricular tachycardia ablation	Patients underwent ablation and not having amiodarone after the procedure

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	six months	Death, ICD intervetion

Trial Locations

Locations (1)

Turkiye Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Ankara, Turkey